Integrating smoking cessation treatment into online psychological care
| ISRCTN | ISRCTN10612149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10612149 |
| IRAS number | 304857 |
| Secondary identifying numbers | IRAS 304857, CPMS 51952 |
- Submission date
- 19/01/2023
- Registration date
- 02/02/2023
- Last edited
- 20/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Smoking is the world’s leading cause of preventable illness and death. People with depression/anxiety are twice as likely to smoke compared to people without depression/anxiety. Quitting smoking can significantly improve your mental health as well as your physical health. Research shows that people with depression/anxiety are more likely to quit smoking if they get psychological support. This study aims to offer service users information about smoking and mental health, and help to quit smoking, alongside their psychological therapy in SilverCloud. The researchers want to see if service users are interested in this support to quit smoking and if this support and the tasks involved in the study are acceptable to patients and to mental health professionals.
Who can participate?
Adults who are regular tobacco smokers and about to start online therapy using SilverCloud
What does the study involve?
SilverCloud users, who would like to take part, will be randomly allocated to receive one of two treatments (i.e., have a 50/50 chance of receiving either treatment). Participants will either receive information about stopping smoking alongside their usual psychological therapy on SilverCloud (intervention group) or receive information about stopping smoking at the end of their participation in the study (control group).
During the study, the researchers will collect information about participants’ well-being and smoking habit. This information will be collected via an online survey, from SilverCloud, or from their mental health service. Follow-up data about participants’ smoking status, mental health symptoms, and experience with the treatment will be collected three and six months after starting the study via email or telephone. If participants have quit smoking, they will be asked to provide a saliva sample via post to check nicotine levels. Participants will receive a £5 shopping voucher for completing each follow-up.
Participants in the intervention group will be invited to take part in a one-to-one interview at the end of the study to discuss their experiences.
What are the possible benefits and risks of participating?
Quitting smoking is the best thing people can do for their physical health and overall well-being. Participants who take part in the study might increase their chances of quitting smoking. There are unlikely to be risks to participants’ personal safety or health by taking part in this study, as all the treatments offered are part of usual care.
Where is the study run from?
Department of Psychology at the University of Bath (UK)
When is the study starting and how long is it expected to run for?
October 2021 to December 2024
Who is funding the study?
Cancer Research UK (CRUK)
Who is the main contact?
smokingstudy@bath.ac.uk
Contact information
Principal Investigator
Addiction and Mental Health Group
Department of Psychology
University of Bath
Bath
BA2 7AY
United Kingdom
 ORCID ID |
0000-0001-8847-7775 |
|---|---|
| Phone | +44 (0)1225 385091 |
| pcj25@bath.ac.uk |
Public, Scientific
Addiction and Mental Health Group
Department of Psychology
University of Bath
Bath
BA2 7AY
United Kingdom
| ORCID ID |
0000-0003-4401-5426 |
|---|---|
| Phone | +44 (0)1225 385091 |
| smokingstudy@bath.ac.uk |
Study information
| Study design | Two-armed pragmatic online randomized controlled feasibility and pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | IntEgrating Smoking Cessation treAtment into usual online Psychological care for people with common mEntal illness: an online randomised feasibility and pilot study |
| Study acronym | ESCAPE |
| Study objectives | This feasibility and pilot study aims to investigate the feasibility and acceptability to patients and psychological well-being practitioners of a tailored and integrated smoking cessation intervention delivered as part of usual online treatment via SilverCloud, and the feasibility and acceptability of trial procedures. |
| Ethics approval(s) | Approved 23/03/2022, Wales Research Ethics Committee 6 Swansea (Wales National Pool, Sketty Lane, Swansea SA2 8QG; +44(0)1686 252101, (0)2920 230457, (0)7920 565664; Wales.REC6@wales.nhs.uk), ref: 22/WA/0051 |
| Health condition(s) or problem(s) studied | Smoking cessation treatment for patients with common mental illness |
| Intervention | A two-armed, pragmatic, online, randomised, and controlled feasibility and pilot trial will be used to test the acceptability and feasibility of an online smoking cessation intervention, and the trial procedures, offered alongside usual online psychological treatment (via SilverCloud). We will recruit adult smokers who are eligible for online treatment via the SilverCloud mental health treatment platform (e.g., people with anxiety and/or depression). Participants will be randomised via an algorithm in the Qualtrics online platform (https://www.qualtrics.com/uk/) to the treatment arm (i.e., smoking cessation psychoeducational information, behavioural support and medication signposting provided alongside usual online mental health treatment) or control arm (i.e., usual online mental health treatment with signposting to NHS smoking cessation services at the end of the trial). SilverCloud usual care includes a self-guided, online mental health programme, depending on the service, patients are offered supported SilverCloud treatment for approximately 6-12 weeks with up to six online or telephone reviews with a mental health practitioner. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-reported quit attempt (at least 24 hours quit) measured using an online questionnaire at 2, 4, 6, 8 and 10 weeks, and 3-month follow up |
| Secondary outcome measures | 1. Engagement with, and completion of, the online smoking cessation and mental health programmes measured using SilverCloud data over 12 weeks. 2. Self-reported smoking cessation medicine and e-cigarette use measured using an online questionnaire at baseline, 2, 4, 6, 8 and 10 weeks, and 3 and 6 months follow up. 3. Depression and anhedonia (Patient Health Questionnaire; PHQ-9) measured using SilverCloud data at baseline and at 2, 4, 6, 8 and 10 weeks, and 3 and 6 months follow up by online questionnaire 4. Anxiety (General Anxiety Disorder Questionnaire; GAD-7) measured using SilverCloud data at baseline and at 2, 4, 6, 8 and 10 weeks, and 3 and 6 months follow up by online questionnaire 5. Quality of health measured using an online questionnaire at 3 and 6 months follow up 6. Self-reported smoking cessation measured using an online questionnaire at the 3-month follow-up (4-weeks abstinent) and 6-month follow-up (prolonged 12-week abstinence) 7. Saliva cotinine (i.e., 15 nanograms per millilitre), or salivary anabasine (<1ng/ml) if using nicotine, measured to confirm smoking abstinence, using saliva sample testing kits that will be posted to participants with a pre-paid envelope to send to ACM Bioanalytical Services (https://www.acmgloballab.com/bioanalytical-services) laboratory for testing at the 3 and 6-month follow-ups (for those reporting cessations) 8. Patient acceptability and satisfaction with the intervention measured using an online questionnaire and qualitative interview conducted remotely online or by telephone (intervention arm only) at the 6-month follow-up 9. Patient acceptability with the trial procedures measured using an online questionnaire at the 6-month follow-up 9. Clinician acceptability of the intervention measured using an online questionnaire and qualitative interview conducted remotely online or by telephone at the end of the trial 10. Engagement with the mental health treatment service (e.g., number of attended/missed appointments, discharge/completion status) measured using NHS service data collected over 12 weeks |
| Overall study start date | 01/10/2021 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 310 |
| Key inclusion criteria | 1. Adult (aged 18+ years), 2. Self-reported regular (daily or non-daily) smokers 3. Eligible for SilverCloud treatment, according to therapists/psychological wellbeing practitioners 4. Comorbidities are allowed |
| Key exclusion criteria | 1. Aged under 18 2. Non-smoker 3. Not eligible for SilverCloud treatment |
| Date of first enrolment | 07/02/2023 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
Dryden Road
Exeter
EX2 5AF
United Kingdom
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Gipsy Lane
Humberstone
Leicester
LE5 0TD
United Kingdom
Long Leys Road
Lincoln
LN1 1FS
United Kingdom
19 Kingsmead
Farnborough
GU14 7SR
United Kingdom
Calmore
Southampton
SO40 2RZ
United Kingdom
Fieldhead Hospital
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
Randalls Road
Leatherhead
KT22 7AD
United Kingdom
Sponsor information
University/education
Claverton Down
Bath
BA2 7AY
England
United Kingdom
| Phone | +44 (0)1225 388388 |
|---|---|
| nhs-sponsorship@bath.ac.uk | |
| Website | http://www.bath.ac.uk/ |
"ROR" |
https://ror.org/002h8g185 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Current publication and dissemination plan as of 13/03/2025: The manuscript with the results of the feasibility study is to be submitted to Lancet Digital Health a high-impact peer-reviewed journal in the next 2-3 weeks. Previous publication and dissemination plan: Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository: https://researchdata.bath.ac.uk/ At the end if the study, we will archive anonymised research data. Data will be uploaded to the University of Bath’s Research Data Archive (https://researchdata.bath.ac.uk/). All data and data access will be restricted (https://researchdata.bath.ac.uk/policies/). Data is made available to approved bona-fide researchers, after they have signed a data access agreement, the person will be granted access to the University of Bath’s Research Data Archive (https://researchdata.bath.ac.uk/) by the Research Data Services (https://data.blogs.ilrt.org/). Participants will consent to this process at the start of the study. Data stored in the Archive will have a Data Object identifier (DOI). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 19/04/2024 | 22/04/2024 | Yes | No | |
| Statistical Analysis Plan | version 1.0 | 06/03/2024 | 12/11/2024 | No | No |
| Plain English results | 13/03/2025 | 13/03/2025 | No | Yes | |
| Basic results | 20/03/2025 | 20/03/2025 | No | No |
Additional files
Editorial Notes
20/03/2025: Basic results added. Contact details updated.
13/03/2025: The following changes were made to the study record:
1. Plain English results added.
2. The publication and dissemination plan and IPD sharing plan were updated.
3. The intention to publish date was changed from 31/12/2025 to 30/04/2025.
12/12/2024: The intention to publish date was changed from 31/12/2024 to 31/12/2025 and the total final enrolment number was added.
12/11/2024: The statistical analysis plan was uploaded as an additional file.
22/04/2024: Publication reference added.
03/01/2024: A contact was updated.
11/12/2023: The overall end date was changed from 01/08/2024 to 31/12/2024.
01/03/2023: Internal review.
26/01/2023: Trial's existence confirmed by Cancer Research UK.
